Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay

July 10, 2014 updated by: Samantha B. Rodgers, MD, Walter Reed Army Medical Center
Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Military health care beneficiary between the ages of 21-55.

Description

Inclusion Criteria:

  1. Military health care beneficiary between the ages of 21-55.
  2. Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection.
  3. Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by principal investigator or sub-investigator.
  4. Ability and willingness to understand and provide informed consent to participate in this study.

Exclusion Criteria:

  1. Irritated eye reflected by patient statements or finding of "red" eye.
  2. Individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis).
  3. Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
  4. Individuals who are on any topical eye medications.
  5. Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lacritin levels in human tears
Time Frame: 2 minutes after instilling anesthetic eyedrop
2 minutes after instilling anesthetic eyedrop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Medical Center

Collaborators

Eastern Virginia Medical School
University of Virginia
James Madison University

Investigators

  • Principal Investigator: Kraig S. Bower, MD, WRAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (Estimate)

June 18, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WRAMC WU# 07-23021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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